Background Ensuring access to affordable, high-quality pharmaceuticals is essential for global health. However, regulatory requirements vary significantly across markets, influencing manufacturing costs, drug prices, and access to quality medicines. This study examines cost variations in pharmaceutical manufacturing in India for products destined for three distinct regulatory markets: the United States (highly regulated), the World Health Organization (WHO) Prequalification (highly regulated), and India (regulatory stringency comparable to many Lower- and Middle-Income Countries). Understanding these cost differences provides valuable insights for regulators, policymakers, and procurers striving to balance affordability, quality, and accessibility.

Methods The study utilizes a bottom-up costing approach to estimate manufacturing expenses for small-molecule generic drugs produced in India for different regulatory markets. Cost estimates are based on real-world industry data from Sidvim, a pharmaceutical manufacturing consultancy. The analysis distinguishes between capital expenditures (CAPEX) and operational expenditures (OPEX), comparing costs associated with active pharmaceutical ingredient (API) and finished dosage form (FDF) production. To isolate cost variations related to regulatory requirements, the study standardizes manufacturing conditions, including production scale, volumes, and facility utilization.

Results The findings indicate substantial cost differences based on regulatory market. Manufacturing API and FDF for the Indian market incurs 43% lower CAPEX and 47% lower OPEX compared to the U.S. Key cost drivers include regulatory compliance, facility infrastructure, equipment standards, quality control, and personnel costs. Facilities serving highly regulated markets require stringent quality control, high-grade equipment, and frequent inspections, contributing to elevated costs. The study highlights the need for research on trade-offs between affordability and quality. Enhancing international collaboration and regulatory harmonization may facilitate access to high-quality, affordable medicines globally.

Conclusion Cost disparities in pharmaceutical manufacturing underscore the challenge of balancing affordability with quality. Further research is needed to assess how these cost variations impact patient access, informing regulatory strategies and procurement policies across diverse market settings.

The authors have declared no competing interest.

This work was supported by the Gates Foundation.

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